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U-Deebio Usungula iiMveliso eziNtsha eziNcedisa ukuzinzisa uNikezo lweHlabathi lwe-Thyroid API

ENTSHA YORK, NY / ACCESSWIRE / Julayi 7, 2021 / Kutshanje, esinye isiqwenga seendaba ezilungileyo sivela kwishishini le-API ye-bio-enzyme yaseTshayina.Iqela lokuqala le-API ye-thyroid eveliswe nguSichuan Deebio Pharmaceutical Co., Ltd. ithunyelwe e-United States.

Kuxelwa ukuba umsasazi wale mveliso yi-MEDISCA, eyona nkampani inkulu yokudibanisa amayeza e-United States.Ngenxa yokungazinzi kokunikezelwa kwexesha elide, i-MEDISCA ifuna abavelisi be-API ye-thyroid esemgangathweni evela kwihlabathi jikelele ukuya kwimigangatho ye-FDA.Emva kokunxibelelana kwexesha elide kunye nokuphononongwa, i-Deebio, eyaziwayo ngeemveliso zayo eziphezulu, ifikelele ngempumelelo kwintsebenziswano yeqhinga kunye ne-MEDISCA.

Le ntsebenziswano, enefuthe elihle ekunikezelweni kwe-API ephezulu ye-thyroid e-United States, yenze i-Deebio yodwa umenzi we-API we-thyroid e-China kunye nomnye wabavelisi abambalwa be-thyroid API emhlabeni abanokubonelela nge-API ye-thyroid imigangatho ye-FDA.

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Ukuzalisa uMsantsa kwiMarike

Ukunikezelwa kwe-API ye-thyroid kuye kwahlala kuzinzile kwihlabathi jikelele.Ngenxa yeemfuno eziphezulu kakhulu ze-API ye-thyroid esekelwe kwizilwanyana zokhuseleko kunye nokuzinza, kuphela abavelisi abambalwa abahlangabezana nemigangatho ephezulu ukusuka kwizinto eziluhlaza ukuya kwimveliso.Ukongezelela, ukunqongophala kwezinto ezisekelwe kwihagu ezihlangabezana nemigangatho yokukhutshwa kubangele ukungonelanga kwe-API ye-thyroid.

Ubonelelo lufutshane, kodwa imfuno ingxamisekile.Ngokutsho kwedatha yophando ekhutshwe yi-WHO, iziganeko zehlabathi jikelele zezifo ze-thyroid ziphezulu njenge-20%, engaphezulu kwesifo seswekile kwaye iyanda.Amayeza adibeneyo e-thyroid aphakathi kwamalungiselelo aqhelekileyo amiselweyo, adlala indima engenakuthathelwa indawo kunyango lwezifo ze-thyroid.

Ukuhanjiswa okuyimpumelelo kwe-API ye-thyroid ngeli xesha lizalise ngexesha elifanelekileyo i-gap yemfuno kwimarike yehlabathi."Amayeza adibeneyo asebenze iminyaka ukuqinisekisa ukhuseleko lwe-API ye-thyroid," kusho u-Antonio Dos Santos, uMongameli kunye ne-CEO ye-MEDISCA, "Le ntsebenziswano izisa i-MEDISCA inani leenzuzo, ezisenza sikwazi ukuhambisa iimveliso ezikumgangatho ophezulu kakhulu kwimithombo ethembekileyo;eyona nto ibalulekileyo kukuthembeka konikezelo. "

Ukukhokela kwiMigangatho yoMgangatho oPhezulu

I-MEDISCA ifuna kakhulu kubaboneleli bayo.Ngenxa yeepropati ezikhethekileyo ze-API ye-thyroid, i-MEDISCA ibeke iimfuno ezingqongqo ngakumbi kubathengisi bezo mveliso ngokomgangatho, ukungafihli, kunye nodumo lwezoshishino.

"USichuan Deebio Pharmaceutical Co., Ltd ungomnye wabavelisi abambalwa kwihlabathi liphela elikwaziyo ukukhupha i-thyroid kwaye iyinkokeli yokuxhasa imigangatho ephezulu," utshilo uAntonio.

I-Deebio yinkampani ehamba phambili ye-API ephezulu e-China, kunye nokuqokelela okunzulu kwamava kwimveliso, ulawulo, iteknoloji kunye neminye imiba ye-27 iminyaka.Ukususela ekusekweni kwayo, i-Deebio iye yaseka idumela elihle kwishishini elineemveliso ezikumgangatho ophezulu, uluvo oluqinileyo lokunyaniseka nokuthembeka, kunye nokufuna ukuphuculwa rhoqo.Iimveliso zayo ziqinisekisiweyo ze-EU-GMP kunye ne-Chinese GMP eqinisekisiweyo, kwaye ukuya kwi-FDA, i-PMDA kunye nemigangatho ye-MFDS.Ithumela iimveliso kumazwe angama-30, kwaye iliqabane lexesha elide leSanofi, Abbott, Novartis kunye nezinye iinkampani ezixuba amayeza ezaziwayo kumazwe ngamazwe.

Iimpumelelo ezilungileyo zangaphambili zibeke isiseko sekamva eliqaqambileyo likaDeebio.Inganelisekanga ngeemeko zangoku, yenze imizamo engakumbi kunye notyalo-mali ukuvelisa i-API ye-thyroid ukuya kwimigangatho.Akukhona nje ngqongqo ngezinto ezikrwada ukuqinisekisa umgangatho wemveliso kunye nonikezelo oluzinzileyo oluvela kumthombo, kodwa kwakhona utyalo-mali ekwakhiweni kweworkshop yokuvelisa ezinikeleyo efikelela kwimigangatho ye-FDA, ukuze kuqinisekiswe ukuba yonke inkqubo yemveliso evela kwisondlo. , ukutsalwa ekucoceni kufakwe ngokupheleleyo kwaye kuzenzekelayo.

Ukuzalwa kunye nokuhanjiswa okugudileyo koluhlu olutsha lwe-API ye-thyroid ye-Deebio ayizange ibe nengozi, kodwa ingenakuphepheka emva kokuthotyelwa ngokungqongqo kwimigangatho ephezulu kunye nemigudu engapheliyo.

Ukudibanisa Imikhosi Eyomeleleyo yeKamva Lokuphumelela

“Amandla okuqhuba kobu buhlakani kukuzinikela okufanayo kwiinqobo ezisemgangathweni esabelana ngazo.Siqhubela phambili ngokuzithemba kwaye siza kubonelela oosokhemesti ngobonelelo olungaguqukiyo lolona mgangatho uphezulu ngamaxabiso akhuphisanayo.”UAntonio unentembelo enkulu kule ntsebenziswano kunye nophuhliso lwexesha elizayo.

Ukususela kumbono we-thyroid API market e-United States, kule ntsebenziswano, i-Deebio inikezela i-MEDISCA ngokubonelela ngokuzinzile kwe-API ye-thyroid ethembekileyo esemgangathweni kumashishini adibeneyo kunye namashishini angaxutywanga e-United States, kunye namandla ayo abanzi obuchwepheshe, ulawulo. kunye nemveliso, kunye nentsebenziswano yayo elubala kunye negama elihle ishishini.Ikwabonelela ngesiqinisekiso sokusombulula ingxaki yozinzo lokubonelela olufuneka ngokukhawuleza kwimarike yase-US.Ngokuphathelele i-Deebio ngokwayo, ngelixa idibanisa imveliso entsha, ingenisa enye impucuko kulawulo lwayo lonke kunye nenqanaba lokulawula.

Ukusungula izinto ezintsha kunye nophuhliso zimfuza zophuhliso oluzinzileyo lweDeebio.Ngokugqityezelwa kobhaliso ne-MFDS kunye nokungeniswa kwamaxwebhu obhaliso e-PMDA, u-Deebio naye uya kuqhubeka nokufaka isicelo sesiqinisekiso se-FDA.Kwixesha elizayo, iya kuba liqonga lentsebenziswano le-API ye-bio-enzyme ekumgangatho ophezulu, kwaye iya kuphonononga kwaye ibambe amathuba amatsha kunye namaqabane amaninzi ngeli xesha lokukhula okukhawulezayo kwamayeza ehlabathi.

Malunga neSichuan Deebio Pharmaceutical Co.,Ltd

I-Sichuan Deebio Pharmaceutical Co., Ltd yingcali ekhokelayo kwihlabathi kwi-R&D kunye nokuveliswa kwee-enzyme zebhayoloji.Ngeteknoloji ekhethekileyo yokuvelisa i-bio-enzyme yomsebenzi ophezulu, ukucoceka okuphezulu kunye nokuzinza okuphezulu, inikezela ngeemveliso ezigubungela iintlobo ezingaphezu kweshumi, kuquka i-Pancreatin, i-Kallidinogenase, i-Elastase, i-Trypsin-Chymotrypsin, njl. Ukuze ufumane inkcazelo engakumbi malunga ne-Deebio, nceda u tyelelehttp://www.deebio.comkwaye usilandele kwi-LinkedIn (@Deebio).

Malunga MEDISCA

I-MEDISCA yinkokeli ekuboneleleni ngezisombululo ze-turnkey kwishishini lokudibanisa amayeza kunye nabaqeqeshi bezempilo abadibeneyo kwihlabathi liphela.Ngokusebenzisa amahlakani ayo ehlabathi, i-LP3 Network kunye ne-MEDISCA Network, i-MEDISCA izibophelele ekubeni sisixhobo esipheleleyo sababhalisi, oosokhemesti kunye namagcisa ekhemesti abandakanyeka kumayeza omntu ngokunikezela ngoqeqesho lwezemfundo, iimveliso kunye nenkxaso.Yasekwa ngo-1989, inkampani ineendawo eCanada, eUnited States nase-Australia, ilungiselela inkonzo yayo kwimarike yamazwe ngamazwe.


Ixesha lokuposa: Jul-08-2021
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